About Us
At cGMP Consulting, we specialize in providing expert validation, qualification, and compliance services to the life sciences industry. Our team works with clients to ensure their facilities, equipment, and processes meet regulatory standards, enabling the safe and efficient production of pharmaceuticals.
cGMP Consulting is based in Lake Forest, IL. Our main client locations are Melrose Park, IL, North Chicago, IL, Waukegan, IL and Pleasant Prairie, WI.
Position Summary
cGMP Consulting is seeking a senior manufacturing process analyst to support the management of site production metrics. This individual will drive process improvements through the analysis of metrics to improve performance of site. They will support projects that improve manufacturing efficiency and safety, decrease costs, decrease opportunity for human error, or increase compliance. This individual will use SAP, LIMS, PI, POMS and other systems, programs, and databases to input, verify, monitor, and analyze pertinent data. They will be able to identify opportunities for improvement of manufacturing and business processes. They will propose, plan and facilitate the improvement solutions and are responsible for production metrics, standards, and reporting on a weekly basis.
This role requires excellent analytical abilities, the ability to understand complex solutions and processes, and a strong focus on driving data quality improvements. This candidate will work cross-functionally with local and global teams in a GMP-compliant manufacturing environment.
Responsibilities
The essential functions include, but are not limited to the following:
- Works within established systems to improve Good Manufacturing Practices (GMP) compliance
- Reviews data and exercises judgement within generally defined procedures and practices to determine appropriate action
- Tracks ongoing problems and gathers information for analysis
- Analyze data to develop solutions to general-level problems
- Presents a potential solution to management / senior personnel and with assistance creates an implementation plan
- Updates metrics and KPI's and presents data to management and senior leadership regularly
- Leverages knowledge of Python, SQL, Microsoft Power Platform, and Microsoft Office to streamline and increase automation of metrics gathering and ensuring correct data pull, analysis and reporting
- Establish requirements and assist in the implementation of changes to the Process Control System
- Investigates events in production that have opportunity for OPEX improvement
- Leads or participates in RCPS or FMEA sessions
- Documents investigation outcomes and drives for results
- Frequently interacts with functional peer groups
- Interaction normally requires the ability to gain cooperation of others, conduction presentations of technical information concerning specific projects, schedules, etc
- Comply with company policies and procedures, Engineering Standards and Specifications, Plant procedures, and regulatory agencies regulations and requirements
Requirements
- Bachelors’ degree or equivalent required, preferably in an engineering or related field
- 5+ years of experience in manufacturing / production processes with good writing skills
- Working knowledge of safety, quality systems, and current Good Manufacturing Practice as applied to equipment and process steps in area of responsibility is required
- Must be flexible to handle multiple tasks including ability to handle pressure in a professional manner. Effectively work in a team environment. Maintain high level of energy and professionalism on the job. Build effective working relationships with customers, co-workers, cross-functioned groups, and management
- High computer and MS Office skills, Python, SQL, Power Apps, Power BI, and Power Automate
Compensation And Benefits
- Expected pay range per year: $80,000-$115,000 USD
- Expected benefits include: Medical, Dental, Vision, PTO, 401K
Disclaimer
The duties and responsibilities described are not a comprehensive list and additional tasks may be assigned to the employee from time to time; or the scope of the job may change as necessitated by business demands. All duties and responsibilities are subject to possible modification to reasonably accommodate individuals with disabilities. The requirements listed are the minimum levels of knowledge, skills, or abilities necessary to perform this job successfully. The company is an Equal Opportunity Employer, drug-free workplace, and complies with ADA regulations as applicable.
Powered by JazzHR
odKn1uwaAc
